NCT00403143

Brief Summary

To measure colour vision in patients with a blue light filtering lens implant in one eye and non-tinted implant in the other eye (and compared this group with a control group with bilateral non-tinted implants) and to determine whether blue light filtering lenses limit colour vision

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 23, 2006

Completed
Last Updated

May 14, 2007

Status Verified

May 1, 2007

First QC Date

November 22, 2006

Last Update Submit

May 11, 2007

Conditions

Blindness

Keywords

intraocular lens, colour vision, blue-light filtering

Outcome Measures

Primary Outcomes (2)

  • To objectively determine whether colour vision is reduced with a blue-light filtering

  • intraocular lens compared with a colourless intraocular implant in cataract surgery

Secondary Outcomes (2)

  • To determine whether patients subjectively are able to tell whether they have been

  • implanted with yellow tinted intraocular lens during their cataract surgery or colourless one

Interventions

cataract surgeryPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients who have had uncomplicated cataract surgery in one eye and have a cataract in the other eye
  • patients who are over 18 years of age
  • patients who are fully able to independently give consent to have surgery

You may not qualify if:

  • patients who have any other ocular co-morbidity that may account for reduction in vision in either eye (as this may confound the condition)
  • patients who are colour blind
  • patients who suffered previous post-operative complications
  • patients under 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North West London Hospitals NHS Trust

London, NW10 7NS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Blindness

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Vision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Gillian Vafidis, MA FRCS FRCOphth

    London North West Healthcare NHS Trust

    STUDY DIRECTOR

Central Study Contacts

Amynah Goawalla, BSc, MBBS MRCOphth

CONTACT

020 963amynahgoawalla@nwlh.nhs.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 22, 2006

First Posted

November 23, 2006

Study Start

October 1, 2006

Last Updated

May 14, 2007

Record last verified: 2007-05

Locations

GB(1)